MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-12-21 for BERICHROM PROTEIN C 10446499 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[131935974]
The customer contacted a siemens customer care center and reported that different protein c results were obtained on two patient samples using the berichrom protein c reagent. Siemens reviewed the sysmex cs-5100 system back up files and determined that the customer is not using the most recent berichrom protein c application on the sysmex cs-5100 system. The software application used by the customer may not feature re-dilution and it is possible that the customer manually diluted the samples prior to repeating the samples. There is no indication of a software or reagent malfunction and siemens determined that an issue with the manual dilution of the samples potentially contributed to the different protein c results. The sysmex cs-5100 system instructions for use indicates that when results are flagged with error code 0000. 4000. 0041 [extrapolation boundary over (upper)], the operator should change the dilution ratio and repeat the analysis. The reagent is performing according to specifications. No further evaluation of this device is required. Mdr 9610806-2018-00117 was filed for the result obtained on (b)(6) 2018 for sample id (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[131935975]
Flagged non-numerical protein c results were obtained on two patient samples on a sysmex cs-5100 system, using the berichrom protein c reagent. The flagged result for sample id (b)(6) was reported to the physician(s), and it is unknown if the flagged result for sample id (b)(6) was reported to the physician(s). The samples were diluted in a 1:4 dilution and repeated on the same system, using the same reagent lot, resulting in numerical protein c results. The repeat result for sample id (b)(6) was reported to the physician(s). On (b)(6) 2018, sample id (b)(6) was repeated again on the same system and reagent lot, resulting higher than the repeat result. The correct result for either patient is unknown. There are no known reports of patient intervention or adverse health consequences due to the different protein c results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00116 |
| MDR Report Key | 8189356 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-21 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-27 |
| Date Added to Maude | 2018-12-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING- STR. 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERICHROM PROTEIN C |
| Generic Name | BERICHROM PROTEIN C |
| Product Code | GGP |
| Date Received | 2018-12-21 |
| Model Number | BERICHROM PROTEIN C |
| Catalog Number | 10446499 |
| Lot Number | 48671 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-21 |